What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Life Sciences?
Responsibilities :
- Perform validation activities to ensure compliance with government and customer requirements.
- Prepare and execute validation protocols (IOQ, OQ / PQ) and related documentation for new customer / product / system launches.
- Maintain existing validated processes, coordinating internal and customer approvals as needed.
- Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals.
- Assist in the change control process and prepare change control and validation history reports for audits.
- Participate in conference calls and meetings to communicate project goals and progress.
- Investigate validation deviations, document formal reports, and ensure corrective actions are completed.
- Review and approve User Requirement Specifications (URS), Functional Specifications (FS), and Engineering Study Protocols.
- Assist with Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.
- Coordinate validation efforts with mechanics, operators, and engineering teams.
- Complete and pass GDP and GMP training courses as required.
- Perform other duties assigned by managers or supervisors.
- Manage high-risk projects, which may include complex customer needs, stringent validation requirements, and significant time commitments.
Requirements :
